Phase 2 Endometrial Cancer Trial, Recruiting NCT05838521 Sponsor: Yale University Condition: Endometrial Cancer
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Phase 2 Endometrial Cancer Trial, Recruiting

NCT05838521
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have cervical cancer (of epithelial origin) that has been confirmed by a scan (CT or MRI) and has come back or not gone away after at least one prior chemotherapy treatment.
  • You have saved tumor tissue samples (from a previous biopsy or surgery) available for testing.
  • Your cancer can be measured on a scan, with at least one clearly identifiable area of disease to track during the study.
  • Your cancer originally came from any stage (Stage I through IV) and has now returned or spread.
  • Your blood counts are at an acceptable level — enough white blood cells, platelets, and infection-fighting cells (confirm with trial site).
  • Your kidneys are working well enough, based on a blood test (confirm with trial site).
  • Your liver is working well enough, based on blood tests (confirm with trial site).
  • You are physically well enough to carry out everyday activities with little or no difficulty (known as ECOG performance status 0 or 1 — confirm with trial site).
  • You have signed a consent form agreeing to take part in the study.
  • It has been at least 2 weeks since your last cancer treatment (such as chemotherapy, radiation, immunotherapy, or surgery).
  • It has been at least 2 weeks since taking high-dose steroid medications (low doses may still be allowed — confirm with trial site).
  • Any side effects from previous treatments have mostly cleared up (to a mild level or better), with some exceptions for mild nerve-related side effects or hair loss.
  • You have had no more than 2 prior chemotherapy regimens for your cervical cancer.
  • If you received immunotherapy before, at least 4 weeks have passed since your last dose.
  • If you could become pregnant, you have had a negative pregnancy test within 7 days of joining and are using effective contraception during the study and for 12 weeks after treatment ends.
  • You are at least 18 years old.

Who may not be able to join:

  • You are pregnant or breastfeeding.
  • You have had a serious allergic reaction to the study drug or its ingredients.
  • You are taking certain medications that interfere with how the study drug is processed in your body (such as UGT1A1 inhibitors — confirm with trial site).
  • You have other medical or mental health conditions that the study doctor feels could affect your safety or the study results.
  • You have had another type of invasive cancer in the past 5 years (exceptions may be made for certain skin cancers or very early cervical changes — confirm with trial site).
  • You have had a significant heart problem in the last 6 months, such as uncontrolled high blood pressure, unstable chest pain, serious heart failure, or a significant irregular heartbeat.
  • You have a serious ongoing lung condition, such as severe COPD or another chronic breathing illness that was active in the last 6 months.
  • You have any unstable health problem that is currently being treated, such as a recent stroke, blood clot in the lungs, serious infection requiring IV antibiotics, or significant kidney or liver problems.
  • You have active cancer that has spread to the brain or the lining around the brain, unless previously treated brain spread has been stable for at least 4 weeks and all symptoms have returned to normal (confirm with trial site).
  • You have an uncontrolled seizure disorder or active neurological disease.
  • You have HIV with a detectable level of virus in your blood, or are taking medications that may interfere with the study drug.
  • You have active Hepatitis B or C, or a history of either with detectable virus levels.
  • You have a known bleeding disorder.
  • You have a condition called Gilbert's disease (a liver-related condition affecting how the body processes certain substances).
  • You have a single tumor mass larger than 7 cm (though exceptions may be discussed with the lead study doctor).
  • You are currently experiencing moderate or severe loss of appetite, nausea, vomiting, or signs of a bowel blockage.
  • You have had a bowel blockage within the last 6 months.
  • You have previously had a severe allergic reaction to a drug called irinotecan, or had serious side effects from it.
  • You have previously received a type of chemotherapy called a topoisomerase I inhibitor (confirm with trial site).

**Important: Always verify eligibility with the trial site directly before applying

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Alessandro D. Santin, MD, Yale University

Phone: 203-737-4450

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
2 June 2023
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective Response Rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov